Effects of Sucralose on Glucose Metabolism (Sucralose)

November 8, 2017 updated by: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Effects of Sucralose on Insulin Sensitivity, Pancreatic Response and Appetite Regulating Hormones

In this study the effects of sucralose on insulin sensitivity, beta-cell response and appetite regulating hormones will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The consumption of non-nutritive sweeteners has a high prevalence. The effect of non-nutritive sweeteners in both beta-cell function and insulin resistance it is unknown.

Previous studies performed in animal models and humans with diverse characteristics have shown variable effects of different non-nutritive sweeteners in variables related to glucose metabolism.

Due to the high consumption of non-nutritive sweeteners it is relevant to know its effect in beta cell-function and insulin sensitivity.

In this study the effects of sucralose, a non-nutritive sweetener that is highly consumed in the population, on insulin sensitivity and beta-cell function will be evaluated.

54 participants with normal glucose tolerance, normal weight, and without chronic diseases with a low consumption of non-nutritive sweeteners will be included. The participants will be randomly assigned to consume sucralose or to a control group.

During the first visit an oral glucose tolerance test with 75 g of glucose will be performed. Fasting and 2-hour glucose will be measured in order to rule-out diabetes, abnormal fasting glucose, or glucose intolerance.

During the second visit a three-hour IV glucose tolerance test will be performed administering 0.3 g/kg of glucose and insulin 0.03 U/kg. Samples will be taken following the minimal model described by Bergman.

After this visit, the group assigned to receive sucralose will ingest 15% of the adequate daily intake (ADI) of sucralose and the control group will abstain of any non-nutritive sweetener consumption during 14 days. At the end of this period a third visit to repeat the IV glucose tolerance test will be performed.

Samples will be analyzed measuring glucose and insulin concentrations to evaluate acute insulin response (AIR), glucose effectiveness (SG), first phase pancreatic response (ф1), and second phase pancreatic response (ф2). In addition, hormones involved in appetite and satiety (leptin, ghrelin, and peptide tyrosine tyrosine) will be quantified at the beginning and end of the intervention.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • both genders
  • age between 18 and 55 years
  • body mass index ≥18.5 and <25 kg/m2
  • low consumption of non-nutritive sweeteners

Exclusion Criteria:

  • diabetes or glucose intolerance
  • consumption of medications affecting insulin sensitivity (metformin, steroids, hormone replacement therapy, contraceptives)
  • intestinal disease such as malabsorption or previous intestinal resection
  • history of bariatric surgery
  • pregnancy or lactation
  • weight loss greater than 5% in the previous month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sucralose
Ingestion of 15% of the ADI of sucralose daily during two weeks
Other: Sucralose
Other Names:
  • Non-nutritive sweetener
No Intervention: Control
Absence of sucralose ingestion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin sensitivity
Time Frame: Two weeks
Insulin sensitivity and pancreatic response estimated with the minimal model using a frequently sampled IV glucose tolerance test
Two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucagon like peptide (GLP-1) change
Time Frame: Two weeks
Change in fasting GLP-1 after sucralose ingestion
Two weeks
Ghrelin change
Time Frame: Two weeks
Change in fasting ghrelin after sucralose ingestion
Two weeks
Tyrosine-tyrosine peptide (PYY) change
Time Frame: Two weeks
Change in fasting PYY after sucralose ingestion
Two weeks
Leptin change
Time Frame: Two weeks
Change in fasting leptin after sucralose ingestion
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • Principal Investigator: Paloma Almeda-Valdes, MD, PhD, Attending Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

October 15, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1544

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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